FDA Approves IV Combination Acetaminophen, Ibuprofen

The FDA has approved Maxigesic IV (paracetamol/ibuprofen, Hyloris Pharmaceuticals) for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary.

The approval for the New Drug Application is based on positive data from a phase 3 program in which Maxigesic IV demonstrated that it was well tolerated and offered a faster onset of action and higher pain relief, compared with paracetamol IV (acetaminophen IV), ibuprofen IV and placebo. The superior analgesic effectiveness of Maxigesic IV was also supported by various secondary end points, including reduced opioid usage rates, according to Hyloris. 

Maxigesic IV is a combination of 1,000 mg of paracetamol with 300 mg of ibuprofen solution for infusion for use postoperatively. Results from a phase 3, randomized, double-blind, placebo-controlled trial in 276 patients following bunion surgery demonstrated that Maxigesic IV was well tolerated and had a faster onset of action, and offered higher pain relief versus ibuprofen IV or paracetamol IV alone in the same doses.

The analgesic effectiveness of Maxigesic IV was also shown in reduced opioid consumption compared with the paracetamol IV and ibuprofen IV treatment groups (P<0.005). 
To date, Maxigesic IV is licensed for use in over 100 countries, approved in more than 40 countries and marketed in over 20 countries.

Based on a press release from Hyloris.